Events

Alerte De Sécurité sur Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class I, Serial Number: 7501721; 7501821; 7501921; 7502021.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1706
  • Date
    2015-10-01
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Unexpected spills, aerosols, or blood droplets may occur when equipment is improperly unplugged. There are no known cases of serious adverse events. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Inadvertent opening of the sample tube during the transport process with risk of user contamination and sample loss. the root cause of the problem is related to the design of the repellent plate bevel, which is the component of the tube inlet basin.
  • Action
    The company will make a field correction of the equipment in which it will develop a kit of modification for the equipment. Until the corrective measure with the modification kit is implemented, if the problem occurs, the equipment must be cleaned according to the operating manual.

Device

Bulk Loader (BLM), integral module of the Cobas p 512/612; Registration 10287411043; Hazard Class...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH